Change Applications: 8-Day Reception, 90-Day Decision and 30-Day Corrected Resubmission

1. Key takeaways

The time limits of the change channel under the order of 23 June 2021 are as follows:

reception review within 8 days (Article 9) → technical assessment follows Articles 23 to 26 of Executive Decree No. 20-324 (Article 10) → ANPP decides within 90 days of receipt of the change application, extendable by exception by 30 days (Article 12) → notification of the decision within 10 days (Article 13) → after refusal, a corrected change application may be submitted within 30 days (Article 14) → ANPP answers within 30 days of receipt (Article 15).

2. Legal basis

1. Arrêté du 12 Dhou El Kaâda 1442 correspondant au 23 juin 2021 fixant les modalités de modification de la décision d’homologation des dispositifs médicaux à usage de la médecine humaine (Order of 23 June 2021 on the modalities of modification of the homologation decision for medical devices intended for human medicine, JORADP No. 62, published on 15 August 2021, pages 21–22, 16 articles in total), Article 9 (reception within 8 days and the classification check) and Article 10 (assessment under Articles 23 to 26 of Executive Decree No. 20-324); Article 12 (decision within 90 days, extendable by 30 days), Article 13 (three forms of notification within 10 days), Article 14 (corrected application within 30 days) and Article 15 (answer within 30 days).
2. Décret exécutif n° 20-324 du 6 Rabie Ethani 1442 correspondant au 22 novembre 2020 relatif aux modalités d’homologation des dispositifs médicaux (Executive Decree No. 20-324 of 6 Rabie Ethani 1442 corresponding to 22 November 2020 on the modalities of homologation of medical devices, JORADP No. 69, published on 22 November 2020, pages 10–14, 46 articles in total), Articles 23 to 26 (technical assessment and the alternative pathway).
3. Arrêté du 12 Dhou El Kaâda 1442 correspondant au 23 juin 2021 fixant les modalités de modification de la décision d’homologation des dispositifs médicaux à usage de la médecine humaine (JORADP No. 62, published on 15 August 2021, pages 21–22, 16 articles in total), Article 11 (assessment conclusions of strictly regulated authorities or ANPP-recognised bodies may be taken into account).
4. Arrêté du 28 Ramadhan 1442 correspondant au 10 mai 2021 fixant la composition du dossier d’homologation et du dossier de renouvellement de la décision d’homologation des dispositifs médicaux à usage de la médecine humaine (Order of 10 May 2021 fixing the composition of the homologation dossier and the renewal dossier, JORADP No. 55, published on 14 July 2021, pages 21–24, 13 articles in total), Article 5 (submission requires payment of the fee with the payment receipt attached).

3. Expert insights

Insight 1: the starting point under Article 12 is receipt of the application, unlike the standard channel’s date of reception.

Article 12 uses “from the date of receipt of the change application (à compter de la date de réception de la demande)”, whereas Article 30 of Executive Decree No. 20-324 uses “from the date of reception”. The difference means that the 90-day clock of the change channel starts running on the day of filing, without waiting for the 8-day reception review under Article 9 to conclude. Companies should therefore count the deadline from their own submission date, not from any acknowledgement they may receive.

Insight 2: Article 13 splits notification into three forms, and companies must identify which one they have received.

Article 13: the Director General of ANPP notifies within 10 days — (1) where the approved change affects the information recorded in the decision, an amended homologation decision is issued; (2) where the approved change does not affect the recorded information, written consent is issued; (3) where the application is refused, a reasoned refusal notice is issued. Only the first form results in a new certificate; the second is merely a letter of consent, which companies should file carefully because it is the only proof of approval for that change.

Insight 3: the corrected application of Article 14 is a deliberately designed remedy channel.

Article 14: within 30 days of receiving the refusal notice, the holder and/or operator may submit a “corrected change application taking the grounds of the refusal into account”. Article 15: ANPP must answer within 30 days of receipt. Among the four steps of the change channel, this is the only one with an expressly written remedy time limit — and the corrected application must answer each refusal ground point by point, not merely restate the original file.

Insight 4: Article 11 embeds a reliance channel.

Article 11: ANPP may take into account assessments already completed by a strictly regulated pharmaceutical authority or a body recognised by ANPP when approving change applications for the devices referred to in Article 6. Although the provision does not define the list of strictly regulated authorities, this is the first time Algerian regulation has recognised foreign assessment conclusions in its text — a small door, but one worth using whenever the paperwork allows.

4. Practical recommendations

1. Set the 90-day countdown from the filing date of the change, without waiting for the reception outcome.
2. On receiving an Article 13 notification, first identify which of the three forms it is; where recorded information is affected, request the new certificate.
3. After refusal, file the corrected application within 30 days under Article 14, answering each refusal ground in turn.
4. When filing a change, prepare in parallel the foreign assessment conclusions usable under Article 11 (approvals by strictly regulated authorities or ANPP-recognised bodies).
5. Submit samples and raw materials with the change dossier as required by Article 8; do not wait for a request.
6. Retain proof of delivery of filings and notifications to build a complete time-limit evidence chain.

5. Verification checklist

• □ The filing date of the change has been set as the start of the 90-day countdown.
• □ Identification criteria for the three notification forms of Article 13 are defined.
• □ The process and template for the corrected application within 30 days after refusal are ready.
• □ Foreign assessment conclusions usable under Article 11 have been prepared in parallel.
• □ Samples and raw materials were submitted with the change dossier under Article 8.
• □ Proof of delivery of filings and notifications has been archived.

Regulatory information verified as of 30 October 2026.

GRZAN provides post-market compliance support for the Algerian market: preparing and filing change applications, tracking the 8-day, 90-day and 30-day time limits, managing refusal responses, and coordinating with ANPP and local partners. For support with changes, recalls and inspection responses in Algeria, contact info@grzanglobal.com.